–(Business Wire)–Highlighting the role of specialty pharmaceuticals as the fastest growing segment of the prescription drug market in the United States, the recent Secon Annual Ultra Orphan Conference:”Emerging Commercialization Strategies for Addressing the Needs of Ultra Orphan Patients — Accelerate Product Launch and Profitability by Building Regulatory Requirements into Distribution,” offered stakeholders insights into industry trends, explained the impact of healthcare reform, and identified opportunities to turn Risk Evaluation and Mitigation Strategies (REMS) into a competitive advantage.

Sponsored by Centric Health Resources, Inc. a new generation health services organization focused on improving the quality of life for people nationwide with rare, orphan, ultra-orphan, and chronic genetic disorders, the conference drew a capacity-audience of representatives from biotech and pharmaceutical companies, patient advocacy organizations, venture capital groups, and consulting firms. Issues impacting stakeholders — ranging from legal concerns, regulatory requirements, managed care reimbursement and patient advocacy – were addressed by some of the most distinguished leaders in the industry.

Setting the tone, Craig Kephart, president and CEO of Centric, articulated the opportunities for manufacturers to transform REMS into a market advantage: “REMS presents a new challenge in the drug approval process, with an average Food and Drug Administration (FDA) delay of nine months due to an insufficient REMS program. While this poses significant implications for manufacturers in this marketplace, it also presents opportunities to integrate REMS with distribution, improve REMS compliance, impact patient compliance, and provide data to support pay-for-performance.”

Keynote speaker Michael McCaughan, editor-in-chief, F-D-C Reports, Inc., Elsevier Business Intelligence, discussed the bright side of biotech, including how the new regulatory model favors highly active medicines for small patient populations, how sponsors who embrace the new model have found it provides a competitive advantage, and how the economics of small markets strongly favor smaller companies over larger entities.

“This conference was about answering critical questions during a time of health care transformation,” Kephart concluded. “Our main focus was to help organizations plan and prepare for new reforms, a potential overhaul of our health care system, and an era of change. We validated the importance of appropriate preparation, and carefully presented the competitive advantages of building REMS requirements into distribution strategies.”

About IPPF

The International Pemphigus & Pemphigoid Foundation’s most important objectives are to provide patients and doctors worldwide with information about pemphigus and pemphigoid, and to provide patients and their caregivers much needed comfort and support so they can continue to live active, productive lives.Read more »